Facility

Bayer Medical Care Inc.

8 recall(s) on record — most severe on record: Class II.

Key facts

8recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006791331
Establishment type	Manufacture Medical Device
Location	150 Victory Road Saxonburg, PA, US 16056
Registration status	Active · expires 2026
Parent company	Bayer Medical Care Inc. (owner-operator 2520313)
Brand names	P3T Cardiac; MEDRAD® Stellant Imaging System Interface Module; MEDRAD Stellant CT Injection System with Certegra Workstation; P3T PA; MEDRAD Stellant Connector Tubing; MEDRAD Stellant FLEX Syringe Kits; MEDRAD Stellant FLEX CT Injection System with Certegra Workstation; P3T Abdomen; Connect.CT; MEDRAD Stellant Syringe Kits; MEDRAD Stellant Single Syringe Tri-Pak with QFT (SSS-CTP-QFT); MEDRAD Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike (SDS-CTP-SCS)

Activity by year

Recalls (8)
Inspections (1)

Devices registered here (1)

Injector And Syringe, Angiographic
Product code DXT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1650

Recalls & enforcement

Class IIOngoing2026-07-31
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Class IIOngoing2026-04-24
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved th…
Class IIOngoing2022-11-30
Black specks may be present on the packaged needles
Class IITerminated2021-09-14
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Class IITerminated2020-10-05
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Class IITerminated2018-12-14
If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
Class IITerminated2018-09-07
Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
Class IITerminated2018-06-28
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disenga…

FDA inspections (1)

NAI2017-01-19
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Bayer Medical Care Inc. (FEI 3006791331) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006791331-bayer-medical-care-inc/

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